Takashi Wada1,2, Eri Muso3, Shoichi Maruyama4, Akinori Hara5, Kengo Furuichi5, Kenichi Yoshimura6, Mariko Miyazaki7, Eiichi Sato8, Masanori Abe9, Yugo Shibagaki10, Ichiei Narita11, Hitoshi Yokoyama12, Noriko Mori13, Yukio Yuzawa14, Takeshi Matsubara15, Tatsuo Tsukamoto3, Jun Wada16, Takafumi Ito17, Kosuke Masutani18, Kazuhiko Tsuruya19, Shoichi Fujimoto20, Akihiro Tsuda21, Hitoshi Suzuki22, Kenji Kasuno23, Yoshio Terada24, Takeshi Nakata25, Noriaki Iino26, Shuzo Kobayashi27. 1. Department of Nephrology and Laboratory Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Faculty of Medicine, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan. twada@m-kanazawa.jp. 2. Division of Nephrology, Kanazawa University Hospital, Kanazawa, Japan. twada@m-kanazawa.jp. 3. Department of Nephrology and Dialysis, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan. 4. Department of Nephrology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan. 5. Division of Nephrology, Kanazawa University Hospital, Kanazawa, Japan. 6. Innovative Clinical Research Center (iCREK), Kanazawa University Hospital, Kanazawa, Japan. 7. Division of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryocho, Aoba-ku, Sendai, 980-8574, Japan. 8. Division of Nephrology, Department of Internal Medicine, Shinmatsudo Central General Hospital, Matsudo, Japan. 9. Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. 10. Division of Nephrology and Hypertension, Department of Internal Medicine, St Marianna University School of Medicine, Kanagawa, Japan. 11. Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. 12. Department of Nephrology, School of Medicine, Kanazawa Medical University, Uchinada, Japan. 13. Department of Nephrology, Shizuoka General Hospital, Shizuoka, Japan. 14. Department of Nephrology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan. 15. Department of Nephrology, Kyoto University, Kyoto, Japan. 16. Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan. 17. Division of Nephrology, Shimane University Hospital, Izumo, Shimane, Japan. 18. Division of Nephrology and Rheumatology, Department of Internal Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan. 19. Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 20. Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan. 21. Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan. 22. Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo, Japan. 23. Division of Nephrology, Department of General Medicine, University of Fukui School of Medical Sciences, Fukui, Japan. 24. Department of Endocrinology, Metabolism and Nephrology, Kochi Medical School, Kochi University, Kochi, Japan. 25. Department of Endocrinology, Metabolism, Rheumatology and Nephrology, Faculty of Medicine, Oita University, Yufu, Japan. 26. Department of Nephrology, Uonuma Institute of Community Medicine, Niigata University Medical and Dental Hospital, Niigata, Japan. 27. Department of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
Abstract
BACKGROUND: Diabetic nephropathy is a leading cause of end-stage kidney disease in the world. Although various types of treatment for diabetes, hypertension and dyslipidemia have improved prognosis and quality of life in patients with diabetic nephropathy, there still exist some diabetic patients with severe proteinuria showing poor prognosis. This clinical trial, LICENSE, aims to confirm the impact of LDL apheresis on proteinuria exhibiting hyporesponsiveness to treatment. METHODS: This ongoing trial is a multicenter, prospective study of diabetic patients with severe proteinuria. The objective is to examine the impact of LDL apheresis on proteinuria in patients with diabetic nephropathy. The other subject is to investigate safety of LDL apheresis in these patients. RESULTS: The subjects consist of diabetic patients with serum creatinine (Cr) levels below 2 mg/dL who present severe proteinuria above 3 g/g Cr or 3 g/day and LDL cholesterol above 120 mg/dL. The target number of registered patients will be 35 patients. Urinary protein excretion and renal function will be observed for 24 weeks after the treatment of LDL apheresis. CONCLUSION: This study will determine the effectiveness and safety of LDL apheresis for diabetic nephropathy patients with severe proteinuria and dyslipidemia.
BACKGROUND:Diabetic nephropathy is a leading cause of end-stage kidney disease in the world. Although various types of treatment for diabetes, hypertension and dyslipidemia have improved prognosis and quality of life in patients with diabetic nephropathy, there still exist some diabeticpatients with severe proteinuria showing poor prognosis. This clinical trial, LICENSE, aims to confirm the impact of LDL apheresis on proteinuria exhibiting hyporesponsiveness to treatment. METHODS: This ongoing trial is a multicenter, prospective study of diabeticpatients with severe proteinuria. The objective is to examine the impact of LDL apheresis on proteinuria in patients with diabetic nephropathy. The other subject is to investigate safety of LDL apheresis in these patients. RESULTS: The subjects consist of diabeticpatients with serum creatinine (Cr) levels below 2 mg/dL who present severe proteinuria above 3 g/g Cr or 3 g/day and LDL cholesterol above 120 mg/dL. The target number of registered patients will be 35 patients. Urinary protein excretion and renal function will be observed for 24 weeks after the treatment of LDL apheresis. CONCLUSION: This study will determine the effectiveness and safety of LDL apheresis for diabetic nephropathypatients with severe proteinuria and dyslipidemia.
Authors: T Nakao; M Yoshino; H Matsumoto; T Okada; M Han; H Hidaka; T Shino; C Yamada; Y Nagaoka; T Miyahara Journal: Kidney Int Suppl Date: 1999-07 Impact factor: 10.545
Authors: Dick de Zeeuw; Giuseppe Remuzzi; Hans-Henrik Parving; William F Keane; Zhongxin Zhang; Shahnaz Shahinfar; Steve Snapinn; Mark E Cooper; William E Mitch; Barry M Brenner Journal: Kidney Int Date: 2004-06 Impact factor: 10.612